Clinical trials are needed to test new drugs. There are different phases in clinical trials, and different types of trial design.
Progressive MS is a big challenge for people who design clinical trials, because disability progression is slow, and there are no MRI or laboratory findings that can be used as prognostic factors (indicators of the future course of the disease).
The most common way to check disability progression in clinical trials is the Expanded Disability Status Scale score, or EDSS. But this scale to rate disability in MS is not completely efficient and can be subjective.
There is a growing awareness that therapeutic effectiveness cannot be fully evaluated without the patient’s perspective.
In February, the Multiple Sclerosis Journal published a study of 132 people with progressive MS. The study was carried out at the VU University Medical Center in the Netherlands. The researchers used a questionnaire for patient-reported outcomes, measuring the impact of MS on people’s daily lives.
The researchers found that the score of this questionnaire is particularly sensitive to change in the more disabled patients and is correlated with change in another clinical measurement, the Timed-25 foot walk test (T25FW, a simple and quick walking test.)
According to this research, therefore, it seems that change in T25FW is strongly correlated with disease impact. This justifies the use of T25FW in progressive MS clinical trials as an appropriate outcome measurement of progression.